FDA-Device2025-08-06Class II
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
FUJIFILM Healthcare Americas Corporation
Hazard
Devices had an unapproved slabbing software function enabled for use.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Chile, Ecuador.
Affected count
293 units
Manufactured in
81 Hartwell Ave Ste 300, Lexington, MA, United States
Products
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2219-2025Don't want to check this manually?
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